MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 DR-T DF4 PROMRI; ICD

Model Number	429524
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.16 months, it was reported that the device shows the eos status.The icd was explanted.
Additional Manufacturer Narrative
Upon receipt, the device interrogation revealed the eos battery status.A number of six charging cycles was documented.The inspection of the icd memory content confirmed a premature detection of the eos battery status on january 31st, 2022.The current consumption of the device in the eos state was tested and was found to be normal.Therefore, the icd was opened to examine the inner assembly.A visual inspection showed no anomalies.The battery voltage was measured revealing a depleted battery.In a next step, the electronic module was attached to an external power supply.The eos status was removed with a technical programmer and the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied, and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.Further extensive analysis of the electronic components and the device memory content was performed, indicating an intermittent elevated current consumption, that could be narrowed down to an integrated circuit on the electronic module.Based on all available information, the root cause for the intermittent elevated current consumption was, however, not conclusively determinable.The manufacturing records and quality documents for this device were re-investigated.No anomalies were documented during the device manufacturing, in particular during the final acceptance test no abnormality in the current consumption of the device was observed.

• Brand Name: ACTICOR 7 DR-T DF4 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13477014
• Report Number: 1028232-2022-00669
• Device Sequence Number: 5101087
• Product Code: MRM
• UDI-Device Identifier: 04035479156695
• UDI-Public: 04035479156695
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 429524
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown